Rexahn Pharmaceuticals Completes Patient Enrollment in Serdaxin Phase IIb Clinical Trial for Major Depressive Disorder
ROCKVILLE, Md.--(BUSINESS WIRE)-- Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced that it has completed enrollment in its Phase IIb clinical trial of Serdaxin(R) to treat major depressive disorder (MDD). The randomized, double blind, and placebo-controlled study began enrollment in January 2011 and enrolled a total of 300 patients at approximately 40 sites in the United States. The Company expects to report preliminary findings from the trial in late 2011. The primary efficacy endpoint of the study is the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS).
"We are very excited by the speed at which we've completed enrollment in our Phase IIb trial for Serdaxin and believe that this further validates the current unmet need for an effective treatment for major depressive disorder," said Rick Soni, President and Chief Operating Officer. "We look forward to completing the trial and announcing preliminary results before the end of the year."
About Serdaxin(R)
Serdaxin(R) is a potential market-leading CNS neuroprotective agent and antidepressant. Rexahn is currently investigating Serdaxin as a treatment for depression, in a large Phase II clinical trial. Serdaxin may achieve greater and broader therapeutic coverage and appears to be safe and well tolerated without the appearance of serious side effects that are commonly linked to currently marketed antidepressant drugs, such as selective serotonin uptake inhibitors (SSRI), serotonin-norepinephrine reuptake inhibitors (SNRI), and tricyclic antidepressants (TCA). Serdaxin has a well-established, excellent human safety profile. In preclinical studies, Serdaxin had onset of action in less than two days.
Based on its novel mechanism as a dual serotonin and dopamine enhancer, it is a potential treatment for multiple CNS disorders where these neurotransmitters are depleted or implicated in CNS-based illnesses, such as Parkinson's disease (PD). Serdaxin has the potential to address both non-motor and motor events of PD by serving as a neuroprotective agent and addressing loss of dopaminergic neurons that lead to loss of control of movements; and further, enhancing serotonin and dopamine levels that are involved in depression and mood disorders. Rexahn has multiple clinical programs planned for investigating Serdaxin in the treatment of anxiety disorders, Parkinson's disease, Alzheimer's disease and neurodegenerative illnesses, neuroprotection and biodefense uses.
About Rexahn Pharmaceuticals, Inc.
Rexahn Pharmaceuticals is a clinical stage pharmaceutical company dedicated to developing and commercializing first in class and market leading therapeutics for cancer, CNS disorders, sexual dysfunction and other unmet medical needs. Rexahn currently has three drug candidates in Phase II clinical trials, Archexin(R), Serdaxin(R), and Zoraxel(TM) - all potential best in class therapeutics - and a robust pipeline of preclinical compounds to treat multiple cancers and CNS disorders. Rexahn also operates key R&D programs of nano-medicines, 3D-GOLD, and TIMES drug discovery platforms. For more information, please visit www.rexahn.com.
Safe Harbor
To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about Rexahn's plans, objectives, expectations and intentions with respect to future operations and products and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause Rexahn's actual results to be materially different than those expressed in or implied by Rexahn's forward-looking statements. For Rexahn, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of Rexahn's licensees or sublicensees; the success of clinical testing; and Rexahn's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect Rexahn's actual results are described in Rexahn's filings with the U.S. Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this press release speak only as of the date of this press release. Rexahn undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Source: Rexahn Pharmaceuticals, Inc.
Released June 22, 2011